Method and apparatus for dermatological treatment

ABSTRACT

Exemplary methods and systems can be provided for resurfacing of skin that include formation of a plurality of small holes, e.g., having widths greater than about 0.2 mm and less than about 0.7 mm or 0.5 mm, using a mechanical apparatus. Compressive and/or tensile forces can then be applied to the treated region of skin as the damage heals to facilitate hole closure, and provide enhanced and/or directional shrinkage of the treated skin area.

CROSS-REFERENCE TO RELATED APPLICATION(S)

The present application relates to and claims priority from U.S.Provisional Patent Application Ser. No. 61/668,744 filed Jul. 6, 2012,the disclosure of which is incorporated herein by reference in itsentirety.

TECHNICAL FIELD

The present disclosure relates to cosmetic methods and systems forimproved fractional resurfacing of skin tissue and similar procedures,specifically, such methods and systems that facilitate enhanced and/ordirectional reduction in skin area or reduction of wrinkles.

BACKGROUND

There is an increasing demand for repair of or improvement to skindefects, which can be induced by aging, sun exposure, dermatologicaldiseases, trauma, surgical procedures, heredity, and the like. Skinloses its tone and smooth texture as it ages, commonly developingwrinkles and laxity. This can be further compounded by photodamage andother effects such as, e.g., scarring from trauma, age-related rhytides,and striae. Aged skin is characterized by a flattened dermal-epidermaljunction, thinning epidermis and dermis, less fibrous collagen, andalterations in elastin organization. Skin rejuvenation therapies work toremove these damaged tissues and/or and stimulate the growth of new,healthy collagen, elastic fibers and skin cells and thereby improve theappearance of the skin.

Reduction in the appearance of wrinkles is an objective of manydermatological procedures and treatments. For example, a face liftoperation is a standard surgical procedure in which skin is removed fromin front or behind the ears, which pulls and lifts adjacent skin fromthe face and neck that has sagged during aging. However, the result ofthis procedure is often an unnatural stretched appearance. If skin onthe face or neck itself could be removed in a way that decreases thearea of skin, with preference to one or more given directions forreduction of skin area, and without visible scarring, the result wouldbe a more natural appearance while still removing unwanted sagging orredundant skin.

Certain treatments may be used to improve skin defects by irradiatingthe skin with electromagnetic energy, which can lead to beneficialresponses to improve the treated skin condition. A common procedure forskin rejuvenation, i.e., laser resurfacing, uses light energy to heatand damage the upper dermis. However, laser resurfacing has a poor sideeffect profile, with many patients experiencing prolonged erythema,scarring and dyspigmentation.

Recently, the development and use of fractional skin therapy hasachieved better results. Fractional damage can include forming smallregions of damage in tissue (e.g., ablation or thermal damage) that aresurrounded by healthy tissue. A small size of the damaged regions (e.g.,generally less than about 1 mm) and proximity of healthy tissue canfacilitate a rapid healing of the damaged regions, as well as otherdesirable effects such as tissue shrinkage. Laser-based fractionalresurfacing techniques and devices involve the use of expensive andpotentially dangerous lasers or other sources of intense optical energyto damaged tissue. Such optical systems can be expensive, present safetyhazards, and require a skilled physician or clinician for theiroperation. Further, fractional resurfacing treatments tend to producegeneral tightening of the skin that has no directional preference orbias.

However, many wrinkles tend to present on certain parts of the body witha general orientation, such as wrinkles extending laterally from thecorners of the eyes or mouth, or along the neck beneath the jaw.Directional shrinkage of skin can be achieved by removing elongatedareas of skin in an appropriate shape, and then joining the edges ofremaining skin (e.g. with sutures) to “pull” the skin back in aparticular direction. Such procedures, as used in conventionalfacelifts, create large scars that must be carefully located, and maygenerate some unnatural-looking shrinkage in response to the large-scaleremoval and repositioning of the skin.

It has been proposed to remove smaller portions of skin, e.g. on theorder of a few millimeters wide, and to close the resulting holes withsutures or the like to produce a more controlled reduction of skin area.Such holes should be elongated (e.g. lenticular or elliptical in shape)to facilitate their closure by approximating their longer edges andavoid the formation of dog-ears when they are collapsed. However, suchholes are still large enough to produce visible markings when healed,and full healing time may require up to a few weeks. Further, closure ofsuch holes is a skill-intensive procedure that would requiremanipulation such as individual suturing or manual, even approximationfollowed by application of an adhesive coating such as a cyanoacrylateadhesive to keep the holes closed until they heal. Such hole closureprocedures would be time-intensive and prone to visible scarring.

Accordingly, there may be a need for a relatively simple, inexpensive,robust and safe cosmetic method and system that can be mechanical innature, and would overcome at least some of such exemplary deficienciesdescribed above, and that can be configured to produce fractional damagein biological tissue that leads to directional reduction of skin surfacearea without causing visible scarring.

SUMMARY

The present disclosure relates to exemplary embodiments of simple,inexpensive, and safe cosmetic methods and systems for mechanicalgeneration of a plurality of small holes, e.g., microregions of damage,in biological tissue, such as skin, and for manipulating the treatedskin to generate a cosmetically desirable reduction of skin area thatcan be enhanced and/or that has a particular or preferred direction.Such exemplary holes can have a width or diameter that is, e.g., betweenabout 0.2 mm and 0.7 mm, or preferably between about 0.2 mm and 0.5 mmas measured along the tissue surface. Such holes can extend into orpreferably through the entire thickness of the dermis. The fractionalarea of skin removed by formation of such holes in a treatment regioncan be between about 5% and 50%, or between about 10% and 30%. Formationof holes in this sub-millimeter size range and areal coverage iswell-tolerated by the body, with minimal risk of scarring, infection, orother complications.

An exemplary embodiment of a cosmetic method according to the presentdisclosure can be provided that can include a formation of a pluralityof holes in a region of skin as described above, and then an applicationof tensile and/or compressive stresses in a direction generally alongthe surface of the skin to the treated region during subsequent healingprocess. Such stresses can enhance overall reduction in the treatedregion and/or provide a directional bias to the resulting shrinkage. Theapplied stresses can be maintained in the treated region until the holeshave substantially closed and/or tissue regrowth has been effectivelymodified, e.g., between about 4-6 days or longer. In certain exemplaryembodiments, this time period may be much shorter, e.g., on the order ofseveral minutes or hours, if a tissue adhesive, glue, or the like isused to facilitate hole closure.

In one exemplary embodiment, a pre-stretched or heat-shrinkable film canbe adhered to the surface of the treated region after the holes areformed. The resulting compressive stresses can enhance hole closure inthe direction of the applied stresses and/or affect the orientation ofcollagen or other structures that grow or evolve as part of a healingresponse in the tissue surrounding the small holes. A rigid film, plate,or other object can optionally be adhered over the stretched film toprovide mechanical stability and maintain deformation of the treatedregion during the primary healing process.

In further exemplary embodiments, compressive stresses can be generatedin the treated region of skin by applying one or more surgical staplesand/or sutures to the area. The staples and/or sutures are preferablylarge, such that they span several of the formed holes, and optionallythe entire treated region. In certain embodiments, a plurality ofstaples or sutures can be applied to a single area at differentorientations, to provide omnidirectional compressive stresses that canenhance hole closure and overall shrinkage of the treated region ascompared to a similarly-treated region without the applied stresses.

In other exemplary embodiments, compressive stresses can be generated byapplying a shrinkable material to the skin surface after the holes areformed therein. The shrinkable material can include, e.g., a heat-shrinkfilm adhered to the skin surface and then heated, a liquid layer thatcan polymerize or react to form an adherent film that reduces in size asit forms, cures or ages, etc.

In other exemplary embodiments, a photoactivated adhesive can be appliedto the surface of the treated region, and a compressive or tensilestress can be generated in the region while directing alight energy ontothe region to activate the adhesive. The photoactivated adhesive caninclude, e.g., rose bengal or any other photoactivated biologicaladhesive known in the art.

In still further exemplary embodiments, tensile stresses can begenerated in the treated region of skin by stretching the treated regionin one or more directions along the skin surface, which can facilitatehole closure and shrinkage in a direction orthogonal to the direction ofthe applied tensile stress. Such tensile stresses can be manuallygenerated and then maintained, e.g., by adhering a rigid film, plate, orother object to the stretched area of skin.

According to further exemplary embodiments of the present disclosure, asystem can be provided for generating a plurality of holes in a regionof skin that includes one or more coring needles that can remove smallcores of tissue by inserting and withdrawing the needles from the skin.A plurality of such needles can be affixed to a substrate to facilitatemotion and positioning of all of the needles simultaneously. Insertionand withdrawal of the needles can be controlled by an actuator, whichcan control the positioning of the needles and/or the substrate, ifpresent, via a mechanical coupling or actuation of an electrical orpneumatic translator or the like.

The exemplary system can further include a compression arrangementcapable of or configured for applying a compression device or substanceto deform the treated region after the holes are formed therein. Forexample, the compression arrangement can include a surgical stapler, asuturing device, an applicator capable of applying a stretched film or acurable/shrinkable liquid to the skin surface, etc.

The herein described exemplary embodiments pertain to cosmetic methodand apparatus. It shall further be noted that the herein describedcosmetic method has been tested, and is a safe and routine procedurethat can be practiced in beauty parlors or other settings. The presentedmethod is a minimally-invasive a method. Moreover, the exemplary methodis safe as it does not present a substantial health risk, and does notrequire professional medical expertise to be performed. No clinician isneeded to perform the exemplary embodiments of the method describedherein, and little or no risk, much less a health risk, is presented fora person being treated with said cosmetic method if standard cleanlinessand sterilization procedures are employed, as shall become apparent fromthe following description.

Synergetic effects may arise from different combinations of the featuresand embodiments described herein, although all such combinations mightnot be described in detail. Further, it shall be noted that allembodiments of the present disclosure concerning method or systemaccording to the exemplary embodiment of the present disclosure, mightbe carried out with the order of the steps or procedures as described,nevertheless this has not to be the only and essential order of thesteps of the procedures of the method and the system. All differentorders and combinations of the steps and procedures are herewithdescribed.

These and other objects, features and advantages of the presentdisclosure will become apparent upon reading the following detaileddescription of exemplary embodiments of the present disclosure, whentaken in conjunction with the appended drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further objects, features and advantages of the present disclosure willbecome apparent from the following detailed description taken inconjunction with the accompanying figures showing illustrativeembodiments, results and/or features of the present disclosure, inwhich:

FIG. 1A is a top view of a round hole that can be formed in skin tissue,in accordance with exemplary embodiments of the present disclosure;

FIG. 1B is a top view of an array of the holes such as that shown inFIG. 1A;

FIG. 1C is a top view of an elongated hole that can be formed in skintissue, in accordance with further embodiments of the presentdisclosure;

FIG. 1D is a top view of a lenticular-shaped hole that can be formed inskin tissue, in accordance with still further embodiments of the presentdisclosure;

FIG. 2 is a schematic illustration of a coring needle that can be usedto form small holes in a biological tissue such as skin, in accordancewith exemplary embodiments of the present disclosure;

FIG. 3A is a schematic side view of a stretch film, in accordance withfurther exemplary embodiments of the present disclosure;

FIG. 3B is a schematic side view of the exemplary film shown in FIG. 3Abeing applied to the surface of a region of skin containing holestherein;

FIG. 3C is a schematic top view of the region of skin shown in FIG. 2Bwith the exemplary film applied to the surface thereof;

FIG. 3D is a schematic side view of the exemplary film applied to thesurface of the region of skin as shown in FIG. 3B, with a rigid objectadhered to the top of the stretch film to stabilize it mechanically;

FIG. 4A is a schematic side view of a surgical staple that can be usedto compress a region of skin tissue, in accordance with furtherexemplary embodiments of the present disclosure;

FIG. 4B is a schematic side view of the staple shown in FIG. 4A that isapplied to a region of skin containing holes therein;

FIG. 4C is a schematic side view of a tensioning clip that is applied toa region of skin containing holes therein in accordance with certainexemplary embodiments of the disclosure;

FIG. 5A is a schematic side view of a suture that can be used tocompress a region of skin tissue, in accordance with further exemplaryembodiments of the present disclosure;

FIG. 5B is a schematic top view of a plurality of sutures such as thatshown in FIG. 5A that are applied to a region of skin containing holestherein in a first configuration;

FIG. 5C is a schematic top view of a plurality of sutures such as thatshown in FIG. 5A that are applied to a region of skin containing holestherein in a second configuration;

FIG. 6A is a schematic top view of a tensile stress being applied to aregion of skin containing holes therein;

FIG. 6B is a schematic top view illustrating the effect of the tensilestress shown in FIG. 6A on the holes;

FIG. 7 is a schematic side view of an exemplary apparatus formechanically generating fractional damage in tissue and providing acompressive stress to the tissue, in accordance with further exemplaryembodiments of the present disclosure;

FIGS. 8A-8C are exemplary images of a region of porcine skin taken atvarious times, showing the size and shape changes arising fromfractional damage generated therein followed by applied stresses; and

FIGS. 9A and 9B are bar graphs of exemplary data showing the observedchanges in width and height of regions of porcine skin fractionallydamaged with coring needles, normalized by corresponding size changes ofuntreated regions.

Throughout the drawings, the same reference numerals and characters,unless otherwise stated, are used to denote like features, elements,components, or portions of the illustrated embodiments. Similar featuresmay thus be described by the same reference numerals, which indicate tothe skilled reader that exchanges of features between differentembodiments can be done unless otherwise explicitly stated. Moreover,while the present disclosure will now be described in detail withreference to the figures, it is done so in connection with theillustrative embodiments and is not limited by the particularembodiments illustrated in the figures. It is intended that changes andmodifications can be made to the described embodiments without departingfrom the true scope and spirit of the present disclosure as defined bythe appended claims.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Exemplary embodiments of the present disclosure relate to cosmeticmethods and systems for generating a plurality of small holes in skintissue and then manipulating or compressing the treated region in aparticular direction, which can result in a locally directionalreduction of skin surface area without visible scarring.

According to exemplary embodiments of the present disclosure, aplurality of small holes 100, such as the hole shown in the top view ofFIG. 1A, can be formed mechanically in skin tissue, e.g., by a coringprocedure as described in more detail below. The width or diameter ofthe holes 100 can be between 200 microns and 700 microns, or preferablybetween 200 microns and 500 microns. The small sizes of such holes canavoid the formation of visible markings or scars after the surroundingtissue heals. Forming holes in this size range is also well-toleratedand safe, because of the very small size of the damaged regions formedand the presence of undamaged adjacent tissue to promote rapid healing.

The holes 100 can be substantially round as shown in FIG. 1A. Aplurality of such holes 100 can be formed in a treatment region of skinor other tissue, e.g., as shown in FIG. 1B, to promote a general healingreaction over the treated region. Such a healing reaction may, forexample, stimulate contraction of existing collagen and/or growth of newcollagen in the treated region in response to the mechanical damagegenerated by formation of the holes 100.

For example, the holes 100 can be formed using a pronged hollow needle200 such as that shown in FIG. 2. This exemplary needle 200 has 2pointed prongs, and can be formed, e.g., by abrading opposite sides ofthe distal end of a hollow needle at an angle relative to the axis ofthe needle. Other needle geometries can also be used, e.g., the needles200 having more than 2 pointed prongs. Such pronged needle 200 (asopposed to, e.g., a conventional biopsy-type needle having a circularcutting end) can facilitate penetration of the end of the needle 200into the skin and removal of small cores of tissue to form the holes 100without rotating the needle 200. These needles 200 can be formed, e.g.,from conventional syringe needles having a gauge between about 19 and27, e.g., having an internal diameter between about 700 microns (0.7 mm)and about 200 microns (0.2 mm). Preferably, the needle gauge can bebetween 21 and 27, corresponding to an internal diameter between about0.5 mm and about 0.2 mm. Coring needles 200 can also be formed fromother types of hollow tubes having an internal diameter corresponding tothe desired hole width.

Insertion of the needle 200 into skin tissue, and subsequent withdrawaltherefrom, can remove a core of tissue and form a microscopic hole 100.The needle 200 can be inserted to a depth that extends at leastpartially into the underlying dermal layer, or preferably through theentire dermal layer to the underlying subcutaneous fat layer. Insertingthe needle 200 to at least the depth of the subcutaneous fat canfacilitate removal of the tissue core within the needle lumen from thesurrounding tissue, e.g., because the tissue core will be severed fromthe adjacent dermal tissue and the bottom of the tissue core is notstrongly held by the underlying fat. Such mechanical coring proceduresused to generate holes 100 may be accompanied by some minor bleeding,which is not significant and may tend to stop quickly because of thesmall hole sizes.

The hole 100 formed by a 2-pronged needle 200 may be somewhat elongatedin shape, as shown in FIG. 1C. This non-circular shape can result fromthe slightly asymmetrical tissue stretching and cutting that can occurwhen the 2 prongs of the needle 200 pierce the tissue and advance withinit. For example, the hole 100 formed using a 2-pronged coring needle 200can have an aspect ratio (e.g., ratio of length to width incross-section) of about 3:2 at or near the tissue surface.

Other hole shapes can be formed in accordance with certain exemplaryembodiments of the present disclosure, such as the lenticular-shapedhole 100 shown in FIG. 1D. For example, the aspect ratio of thelenticular hole 100 in FIG. 1D can be, e.g., about 3:1, and the angle atwhich the curved sides meet can be about 30 degrees. This ratio (or anaspect ratio close to this) and geometry can facilitate closure of thehole 100 by reducing associated stresses or deformations in thesurrounding tissue. Although the shape of an actual lenticular hole 100formed in soft tissue may not have precisely smooth edges and sharpcorners as illustrated in FIG. 1D, an approximately lenticular shape mayfacilitate closure of such holes 100 as they heal.

In general, the specific shape(s) of the holes 100 may not be importantand/or critical, because the small size scale facilitates approximationof the hole edges in any desired direction without generating unwantedeffects such as “dog ears” or misalignments when they close and healtogether. Needles 200 having more prongs, e.g., 3 or 4 prongs, can beused in further embodiments, where such needles 200 may tend to producerounder holes 100 such as those shown in FIG. 1A.

In further exemplary embodiments of the disclosure, formation ofmicroscopic holes 100 in tissue that are asymmetric or noncircular, suchas the hole 100 shown in FIG. 1C, can be desirable for generatingclosure of holes 100 that is locally and/or macroscopically directional.Such holes 100 that are asymmetric may be closed more easily, e.g., bycompressing the tissue such that the narrow width is further narrowedand opposite sides of the hole 100 are brought into proximity orcontacted with each other. Asymmetric holes 100 can be formed using avariety of techniques and apparatuses in accordance with embodiments ofthe present disclosure.

In one exemplary embodiment, elongated holes 100 can be formed in tissueby stretching the tissue in a direction, and then forming the holes 100in the tissue, e.g., using a mechanical coring needle 200, or anothermechanical device. Upon allowing the tissue to relax, the hole 100 willtend to be somewhat elongated, such as the hole 100 shown in FIG. 1C.

In further exemplary embodiments, the coring needle 200 can be providedin various shapes, e.g., having an elongated non-circular cross section,such that the holes 100 formed in the skin or other tissue by insertingand withdrawing the needle 200 will be elongated in shape.

In general, the shape of a microscopic hole 100 formed in soft skintissue may not have precisely smooth edges and a well-defined shape, andthe precise shape of the holes 100 may not significantly affect thesubsequent directional shrinkage or closure behavior because of theirsmall size (e.g., 0.7 mm or less).

The holes 100 can be formed mechanically such that the fraction ofsurface area removed in the treated region is between about 5% and 50%,e.g., between about 10% and 30%. Such area fractions of removed tissuecan be small enough to promote healing or recovery of the mechanicallydamaged skin by retaining a sufficient amount of healthy tissue aroundeach hole 100, while being large enough to generate a cosmeticallydesirable amount of shrinkage in a single exemplary procedure performedon the treated region as described herein. The particular area fractionof holes 100 can be selected based on factors such as, e.g., the desiredextent of shrinkage, the location of the treated region (e.g., face,neck, arms, etc.), general skin characteristics, etc.

The distribution of the holes 100 can be substantially random, or formedin any of various patterns. For example, a plurality of holes 100 can beformed in the skin or other tissue in a generally square or rectangulararray. In further embodiments, the holes 100 can be formed in an arrayof staggered rows, or in a random pattern. The particular arrangement orpattern of the holes 100 may not be particularly important with respectto shrinkage behavior, e.g., because of the large number and small sizeof the holes 100 in the treated region.

A pattern of the holes 100, such as that shown in, e.g., FIG. 1B, can beformed using a variety of techniques. For example, the holes 100 can beformed mechanically, e.g., using a reciprocating mechanism thattraverses the tissue to form the pattern. The mechanism can include oneor more rows of the coring needles 200, such that staggered rows of theholes 100 can be generated in the skin tissue. In further exemplaryembodiments, the holes 100 can be formed in other patterns that may notbe rows, e.g., in spatially random arrangements, which can be achievedby repeated manual insertion and withdrawal of one or more needles 200at various locations in the treated region.

The density or proximity of the holes 100 can also be varied indifferent regions of the tissue being treated. For example, the holescan be spaced further apart in the peripheral areas or edges of aparticular treated region. Such “feathering” of the removed tissuevolume can facilitate a smoother or gradual transition between theshrunken or tightened skin within the treatment region and the untreatedregion of tissue surrounding it. However, such “feathering” or densitygradients of the holes 100 may not be particularly important forobtaining a continuous directional shrinkage over the treated region,because the large number of small holes 100 can adjust to gradients inskin deformation during the subsequent healing process. For example, thelarge number and moderate to high density of microscopic holes 100 canaccommodate macroscopic gradients in shrinkage with only very minorlocal differences in the closure and healing behavior of each individualhole 100. Such gradients and directionality can be produced, e.g., bythe exemplary manipulation of the treated region after the holes 100 areformed, as described herein below.

The particular shape and size of the treated region in which the holes100 are formed is arbitrary, and can be selected based on the areas ofskin that may benefit from the exemplary methods described herein. Suchmethods can be effective over both small regions (e.g. on the order of asquare cm or less) and larger regions, because of the large number ofsub-millimeter holes 100 used to achieve cosmetic effects as describedherein. For example, the small size of the holes 100 generated at anareal fraction between about 5% and 50% can provide a substantiallyuniform dispersion of such holes 100 when viewed at size scales of about1 cm or larger. Accordingly, the exemplary methods described herein caninclude directional closure of a large number of small holes 100, whichcan well accommodate any gradients in shrinkage that may result withinor adjacent to a particular treatment region, and which may be appliedin treatment regions having arbitrary shapes and extents.

After the holes 100 are formed in skin or other tissue, as describedabove, it is possible to promote closure of the holes 100 by applyingappropriate lateral forces (e.g., compressive or tensile forces) to thetissue in the treated region as it heals. Such forces can facilitatecontact between opposite edges of the holes 100, particularly near thetissue surface, and increase overall shrinkage of the tissue as theholes 100 heal in a closed configuration. Further, anisotropy ordirectionality of the overall skin shrinkage in the treated regionfollowing formation of the holes 100 can be achieved by application ofsuch forces in a particular direction during the subsequent healing orrecovery processes.

In one exemplary embodiment of the present disclosure, a stretch film300 can be used to provide a compressive surface force to the tissuesurface in the treated region and promote hole closure. For example, asshown in FIG. 3A, the film 300 can be pre-stretched in the direction ofthe arrows. The stretch film 300 can then be adhered to the tissuesurface, as shown in the exemplary cross-sectional view of the treatedregion in FIG. 3B. The pre-stretched film 300 can then generate adirectional compressive force along the tissue surface, as shown by thearrows in FIG. 3B. This force can pull together the edges of the holes100, particularly near the tissue surface, to facilitate hole closureand increased shrinkage of the tissue during the healing process. Forexample, the stretch film 300 can be applied such that the direction ofcompressive forces at the tissue surface (indicated by the arrows inFIG. 3B) is in the preferred direction of shrinkage. Hole closureresulting from such compressive forces can result in a closed-holeconfiguration similar to the exemplary configuration shown in the topview of the treated region of FIG. 3C, where the arrows represent thedirection of compressive forces, and the small vertical lines 310represent the approximated edges of the holes 100 at the skin surface.

Materials that can be used to form the film 300 include Tegaderm™,another stretchable polymer, or the like. For example, Tegaderm™ hasadherent properties and can be stretched up to about 30-40% and thenapplied to the tissue surface. Other film materials can also be used infurther embodiments. Such films can be provided with an adhesivesurface, or alternatively can be adhered to the tissue surface using anyappropriate biocompatible glue, cement, or adhesive.

For example, the compressive film 300 can be maintained on the tissuesurface for several days, e.g. about 4-6 days, to facilitate sufficienthealing or modification of the skin tissue while it is held in acompressed state, e.g., to minimize or prevent re-opening of the holes100 or collagen expansion in the compressive direction by externalforces.

In further exemplary embodiments, a stabilizing film 330 (shown in FIG.3D), e.g., a non-stretching film or rigid plate or the like, can beadhered to the upper surface of the film 300 after it has relaxed andcompressed the tissue surface. This stabilizing film 330 can providemechanical stability to the compressed tissue surface to maintain thecompressive state and constrain further displacement (e.g., relaxation)of the compressed tissue during the healing process, for example, toprevent relaxation of the film 300 during the recovery process orprevent detachment of the film 300 from the skin surface. In certainexemplary embodiments, the stabilizing film can be adhered directly tothe skin surface surrounding the treated region, e.g., beyond the edgesof the stretch film 300, instead of or in addition to being adhered tothe top of the stretch film 300.

In another exemplary embodiment of the disclosure, one or more surgicalstaples 400 can be used to apply and maintain a compressive force on thetreated region, as shown in the exemplary cross-sectional views of atreated region in FIGS. 4A and 4B. An exemplary large surgical staple400 (e.g., a staple large enough to span across a plurality of holes100) is positioned over the treated region in FIG. 4A. FIG. 4B shows thecompressive deformation of the treated region by the inserted staple400. The exemplary staple 400 can be used to provide a generalcompression of the treated region of skin, thereby approximating theedges of a plurality of holes 100, as shown in FIG. 4B, rather thanapproximating two opposing edges of a single incision or wound (as istypically done with conventional applications of surgical staples). Suchexemplary use of one or more surgical staples 400 may provide increasedcompression of the skin below the surface of the treated region ascompared to that provided by application of a stretch film 300 to theskin surface (shown in FIG. 3B), because of the anchoring and pullingtogether of tissue below the surface by the staple 400.

In another exemplary embodiment, a tensioning clip 450 as shown in FIG.4C can be used to apply and maintain a compressive stress in thetreatment region. The clip 450 includes two prong arrangements 460capable of being inserted into skin. The prong arrangements 460 can havea sharp point or edge at their distal ends to facilitate penetrationinto the skin, and can be made from any material sufficiently rigid orstrong to support a stress as described below without breaking ordeforming significantly (e.g., a metal or rigid plastic or the like).The prong arrangements 460 can be connected by an elastic material 470,which can be provided as a strap, cord, or the like (e.g., similar to arubber band, small bungee cord, or the like). The elastic material 470can be stretched and the prong arrangements 460 then inserted into skinwithin and/or adjacent to the treatment region that contains holesformed as described herein. The stretched elastic material 470 can thencause the prong arrangements 460 to exert a compressive force betweenthem, as shown by the arrows in FIG. 4C. In this manner, a compressivestress can be generated and maintained over at least a portion of thetreatment area using a tensioning clip 450 that can be easily insertedinto and removed from the skin. The size of the prong arrangements 460and elastic material 470 can be selected based on the size of thetreatment region and/or portion of such region over which a stress is tobe maintained.

According to certain exemplary embodiments, a plurality of staples 400and/or tensioning clips 450 can be applied within and/or across anentire treated region, or a portion thereof. In further embodiments,staples 400 and/or tensioning clips 450 can be oriented in differentdirections on or across the treated region to vary the local preferreddirection of shrinkage and/or to provide increased non-directionalshrinkage of the treated region (e.g., as compared to a conventionalfractional damage procedure that does not compress the treated regionafter holes 100 are formed).

The staple(s) 400 and/or tensioning clips 450, if used, can be retainedin the treatment region for several days, e.g. about 4-6 days, tomaintain a compressive state therein during the healing/recoveryprocess, thereby allowing sufficient healing or modification of the skintissue while it is held in a compressed state. Further, the staples 400and/or tensioning clips 450 can be small or thin in at least onedirection, to avoid formation of visible markings upon their removal. Incertain exemplary embodiments, staples 400 and/or tensioning clips 450can be used that are thin and/or that include several prongs configuredto pierce the skin. Such staples 400 and/or tensioning clips 450 canprovide compressive forces comparable to a single large staple 400 orclip 450 while allowing the individual prongs to be smaller in size toreduce or eliminate formation of markings when such staples 400 and/ortensioning clips 450 are removed.

In yet another exemplary embodiment of the disclosure, one or moresutures 500 can be applied to the treated region apply to maintain acompressive force thereon, as shown in the exemplary cross-sectionalview of FIG. 5A. Each suture 500 can be large enough to span across aplurality of holes 100, thereby promoting directional approximation ofopposing surfaces of the holes 100, as shown in FIG. 5A. Similar to thestaple 400 shown in FIG. 4B, the suture 500 may provide increasedcompression of the skin below the surface of the treated region ascompared to that provided by application of a stretch film 300 to theskin surface.

According to certain exemplary embodiments, a plurality of sutures 500can be applied within and/or across an entire treated region, or aportion thereof. For example, a plurality of the sutures 500 can beapplied substantially parallel across the treated region, as shown inthe exemplary top view of FIG. 5B. The arrows in FIG. 5B indicate thedirection of compressive forces, and the small vertical lines 310represent the approximated edges of the holes 100 at the skin surface.In another exemplary embodiment, the sutures 500 can be applied indifferent directions over the treated region, such as in the exemplaryconfiguration shown in the top view of FIG. 5C, to provide increasednon-directional shrinkage of the treated region. The arrows in FIG. 5Crepresent the local direction of compressive forces, which may tend toomni-directionally or isotropically compress the edges of the holes 100at the skin surface. In still another exemplary embodiment, the sutures500 can be oriented in different directions within or across the treatedregion to vary the local preferred direction of shrinkage within thetreated region.

Similar to the stretch film 300 and the staple 400, the suture(s) 500,if used, can be retained in the treatment region for several days, e.g.about 4-6 days, to maintain a compressive state therein during thehealing/recovery process, thereby allowing sufficient healing ormodification of the skin tissue while it is held in a compressed state.

According to further exemplary embodiments, other devices and techniquescan also be used to apply and maintain compressive forces to theperforated tissue in the treated region such as, e.g., forceps, adhesiveheat-shrink films, surface application of curable liquids such aspolymer precursors that can shrink and adhere to the skin surface asthey cure, etc. Any such heat-shrink films, curable shrinking liquids,and the like that are known in the art may be used with certainembodiments of the present disclosure.

In still further exemplary embodiments, any combination of stretch film300, staples 400, sutures 500, heat-shrink films, and/or curable liquidscan be used to apply and/or maintain stresses or deformations in thetreated region as the holes 100 heal.

According to yet further exemplary embodiments, a tensile force can beapplied to a surface region of tissue to promote closure of holes 100formed therein. For example, a plurality of holes 100 can be formed in atissue as described herein and shown in FIG. 6A. A tensile force can beapplied to the tissue in the direction of the arrows shown in FIG. 6A.Such exemplary tensile force can locally stretch the tissue in thedirection of the arrows, which may cause the lateral sides of the holesto approach and/or contact each other as shown in FIG. 6B. Suchnarrowing of the holes 100 can facilitate closure and healing, andresult in local directional shrinkage of the tissue in a directionorthogonal to the applied tensile force as the holes heal, while tendingto maintain or even slightly expand the skin in the direction of thetensile forces as the tissue damage caused by formation of the holes 100heals.

The tensile force, as illustrated in FIG. 6A, can be applied using anyof a variety of techniques and/or devices. For example, such force canbe applied manually, e.g., by pressing fingers against the skin atopposite sides of the treated region, adjacent to the perimeter thereof.The fingers can then be spread apart to apply the tensile force to thetissue, e.g., to stretch the region of tissue between the finger contactpoints. A rigid or non-stretchable adhesive film or plate can then beadhered to the stretched tissue to inhibit or prevent relaxation of thetissue as the holes heal, thereby maintaining the tissue in a stretchedor tensile state. In a further embodiment, an expander device can beused that includes two or more contact surfaces that can be spreadapart, e.g., a pair of forceps or the like having a flat contact area onthe end of each tip. In a similar manner, the contact areas can bepressed against the tissue and then moved apart mechanically to stretchthe tissue between the contact areas. The contact areas can be providedwith a rough, non-slip, and/or adhesive surface to maintain contact withparticular locations on the skin or tissue surface as the tensile forceis applied, and the expander device can be configured to maintain theexpanded configuration while it is adhered to the skin surface. Othertechniques to stretch the skin locally may also be used with embodimentsof the present disclosure.

Various additional procedures can be used to promote hole closure andhealing of the holes 100 after they are formed in the tissue. Forexample, the holes 100 can be exposed to saline or other solutions afterthey are formed, to promote hydration and softening of the tissue priorto healing. Such solutions can also facilitate removal of debris orimpurities in the holes, e.g., removal of blood that may be presentafter the holes 100 are formed mechanically using one or more of thecoring needles 200.

In further exemplary embodiments, biocompatible glues or adhesives canbe used to facilitate more rapid adherence of the closed holes 100,e.g., during the healing process. For example, photochemical tissuebonding (PTB) techniques can be used to help attach the holes 100 in aclosed configuration during the healing process. In a PTB process, aphotosensitizer (e.g., rose bengal, riboflavin, porphyrins, chlorins,and the like) can be applied to the tissue after the holes 100 have beenformed therein, but prior to applying the compressive film 300 or acompressive or tensile force as described herein. Photosensitizerprecursors including, e.g., pro-drugs of such photosensitizers, can alsobe used, where such precursors may be metabolized or otherwise activatedto form photosensitizers in the tissue. Such photoactive substances(e.g., photosensitizers or precursors) can promote tissue bonding whenapplied to tissue, optionally activated or allowed to metabolized, andthen exposed to light having one or more appropriate wavelengths.

After the holes 100 are directionally compressed using the stretch film300, staple(s) 400, suture(s) 500, and/or other compressive or tensileforces, the tissue can be exposed to light having an appropriatewavelength to activate the tissue bonding, to promote adhesion of thehole walls within a few minutes. The choice of wavelength can be basedon the particular photosensitizer or precursor used. The material and/orobject(s) imposing compressive and/or tensile forces in the treatedregion can then be removed while the holes 100 remain closed at thetissue surface and continue to heal.

According to yet further exemplary embodiments, the stretch film 300 canbe provided with a layer of one or more photosensitizers or precursors,such that at least a portion of the photoactive substance(s) istransferred onto the tissue surface when the film 300 is applied to thesurface of the tissue. For example, the photoactive substance(s) can beprovided in a gel or micro-encapsulated layer on the surface of the film300 that is placed against a skin surface. The activating light can thenbe directed through the top surface of the film 300 and onto thecompressed tissue surface and the photoactive substance applied thereon.In general, one or more of the various conventional photochemical tissuebonding systems, materials, and methods can be used to facilitate morerapid hole closure in accordance with embodiments of the presentdisclosure.

In further exemplary embodiments, other tissue glues such as, e.g.,cyanoacrylates, can be used to glue the holes 100 together after theyare formed and compressed, stretched and/or closed. It may be preferableto limit application of such glue to the tissue surface and avoidintroduction of them within the holes 100, to avoid filling them withunwanted material that may inhibit subsequent hole closure andshrinkage. The use of any conventional tissue-bonding techniques ortissue glues, including those described herein, can reduce the amount oftime that the compressive film 300 or other dressings are maintainedover the treated tissue area as it heals, while preventing re-opening ofthe closed holes 100 during the gradual healing process.

As described herein, the shape, density or spacing, and pattern orspatial distribution of the holes 100, and/or the orientation of anapplied compressive or tensile force to the surface of the treatedregion, can provide a directionally-oriented shrinkage of the tissue asit heals. Such directionality can be utilized to achieve improvedcosmetic results by generating increased shrinkage in a preferred localdirection in a mechanical fractional resurfacing procedure. A pluralityof such procedures can be applied to a particular treated region toobtain greater overall shrinkage of the skin or other tissue, preferablyallowing sufficient healing time between subsequent treatments on aparticular area. The compressive and/or tensile directions can be variedin different treatments of a single area to obtain a more homogenousshrinkage of tissue in the area. The sizes and preferred shrinkagedirections of adjacent treated regions can also be selected and variedto achieve desirable overall shrinkage patterns for the skin or othertissue.

Application of a tensile or compressive force to the tissue to promotehole closure can also affect the characteristics of collagen that may beformed during the hole closure and tissue healing processes that occurafter the holes 100 have been formed. For example, collagen may growand/or align in particular directions when forming in tissue that isdeformed by application of external forces after the formation of theholes 100, as described herein. Such modification of collagen growthand/or alignment in the treated tissue may provide further desirablecosmetic effects.

In further exemplary embodiments of the present disclosure, a system canbe provided to generate a plurality of the holes 100 in a treated regionof skin, and then apply a compressive or tensile force to the treatedregion. For example, an exemplary system 700 can be provided thatincludes a handpiece 710 having a lower surface 715, a plurality ofretractable coring needles 200, an actuator handle 720, and acompression arrangement 730, as shown in FIG. 7. The needles 200 can,e.g., be affixed to a movable substrate 725 as a needle array or thelike to facilitate their controllable motion and positioning relative tothe lower surface 715. According to certain exemplary embodiments, theneedles 200 and the substrate 725 can be provided together as a singleunit or cartridge, which can be disposable or reusable/sterilizable. Thelower surface 715 can be configured and/or structured to be placed onthe surface of a treated region, and the actuator handle 720 can becapable of positioning and/or maintaining the needles 200 and/or thesubstrate 725 at one or more locations relative to the lower surface715.

A number of the needles 200 and area of the needle array can be selectedbased on various factors. For example, a number of the needles 200 canbe large enough to facilitate rapid treatment of large areas of skin,but not so large that the cost and complexity of the needle arraybecomes prohibitive. Further, it may be difficult to insert a largenumber of the needles 200 into the skin simultaneously. For example,such number of the needles 200 can be between, e.g., 1 and 50, orbetween about 6 and 25. In certain exemplary embodiments, a largernumber of the needles 200 can be provided in the system 700. The averagespacing between the needles 200 can be selected based on the innerdiameter of the needles 200 and the desired fractional area of skin tobe removed by a single insertion and withdrawal of the needles 200,using simple geometric calculations.

In an exemplary configuration, the system 700 can (e.g., initially) beconfigured such that the distal ends of the needles 200 protrude aparticular distance below the lower surface 715. Such exemplary distancecan be, e.g., the approximate depth of the local dermis of the treatedregion. In certain embodiments, such distance can be adjustable (forexample, using a threaded adjuster or stop, a plurality of steppedsettings or the like, not shown) such that the system 700 can be used totreat skin having various thicknesses.

The exemplary system 700 can be applied onto a treated region until thelower surface 715 of the system 700 contacts the skin surface, such thatthe needles 200 penetrate the skin tissue to the particular distanceinto the skin, e.g., through the entire thickness of the dermis. Theactuator handle 720 can then be squeezed to retract the needles from theskin, pulling the distal ends of the needles 200 above the lower surface715 and forming a plurality of holes 100 in the skin. The actuatorhandle 720 can be further capable of activating the compressionarrangement 730 (not shown) to apply a compression element to thetreated region after the needles 200 have been withdrawn from thetreated region.

In one exemplary embodiment, the compression arrangement 730 can includea surgical stapler configured to be mechanically or electricallyactuated by the actuator handle 720, such that squeezing the actuatorhandle 720 will first withdraw the needles 200 from the treatment siteand then apply one or more large staples 400 and/or tensioning clips 450across at least a portion of the treated region as described hereinabove.

According to another exemplary embodiment, the compression arrangement730 can include a suture needle (e.g. a curved needle) and suturethread. The compression arrangement 730 can be capable of or configuredfor introducing one or more lengths of suture thread below the surfaceof the treated region, e.g., with the ends of the thread protruding fromthe surface of the skin, when it is actuated by the actuator handle 720,after the needles 200 are withdrawn from the treatment site. The ends ofthe suture thread can then be tied together to form a suture 500 thatcan apply a compressive force to the skin tissue in the treated regionas described herein above. Optionally, the compression arrangement 730can be capable of or configured for tying off the suture thread whenactuated, e.g., at a preselected tension.

In yet another exemplary embodiment, the compression arrangement 730 caninclude a stretch film applicator that is capable of and/or configuredfor adhering a stretch film 300 or the like over the treated regionafter the needles 200 are withdrawn from the skin. For example, thecompression arrangement 730 can include a small roll of stretch film 300configured similar to a packing tape dispenser. The system 700 can betranslated over the treated region after the needles 200 are withdrawn,to apply the film 300 over the holes 100 just formed. The film 300 canalso be provided in pre-cut pieces that are sized to fit over thetreated region.

According to a further exemplary embodiment, the compression arrangement730 can include a reservoir of a curable coating material, as describedherein above, and it can be capable of applying such coating material tothe surface of the treated region after the needles 200 are withdrawnfrom the skin. In another embodiment, the compression arrangement 730can be configured or adapted to apply a photoactivated material (orprecursor of such material), as described herein above, to at least aportion of the treated region, and directing light energy onto theregion to activate the material. Embodiments of the system 700 in whichthe compression arrangement 730 is capable of applying other types ofcompression or tensioning elements to the treated region after the holes100 are formed also fall within the scope of the present disclosure.

Example

An exemplary procedure in accordance with certain exemplary embodimentsof the present disclosure was performed on the lower abdomen of a swineanimal model to demonstrate the ability to produce directionalshrinkage. Six test sites, each approximately a 3 cm by 3 cm square,were tattooed onto the animal at Day 0. Seven control sites of the samesize were also marked between the test sites. The control sites wereincluded to account for net growth of the animal over the course ofobservations.

For example, 144 uniformly-distributed holes were made through the depthof the skin in each test site using a specially designed vacuum-assisted19 gauge coring needle. The holes were formed in a substantially randomarray by manually inserting and withdrawing the coring needle 144 timesat arbitrary locations within the test sites. The width of the holesformed was approximately the same as the inside diameter of the needle,e.g., about 0.69 mm. This corresponds to a fractional surface arearemoval within each test site of about 6%. This corresponds to arelatively low fractional amount of skin tissue removed within thepreferred ranges described herein.

A pre-stretched sticky dressing (Tegaderm™) was then adhered onto thetest sites and allowed to retract towards its original size, thuscompressing the tissue as described herein above. Test sites 1, 2, 4, 5and 6 were compressed along the langer lines that run approximatelyhorizontally from head to tail (e.g., in the X direction). Test site 3was compressed across the langer lines (in the vertical or Y direction).No stretched film was applied to the seven control sites.

The dressing was left in place on each test site for seven days and thenremoved. The animal was observed, photographed and the width and heightof each test and control site were measured until day 28.

Photographic images of test site 6 taken at Day 0 (pre-treatment), Day 7(when the dressing was removed), and Day 28, are shown in FIGS. 8A, 8Band 8C, respectively. The sizes of these images were adjusted such thatthe ruler length is the same in each. The overall shape of the test sitechanged from substantially square to rectangular from Day 0 to Day 28,with the width of the test site (in the direction of compression, alongthe langer lines) being about 12% smaller at the end of observationcompared to the initial size of the test site. The height of the testsite (orthogonal to the compression direction) increased by about 17% byDay 28 as compared to the pre-treatment height on Day 0. Further, noapparent scarring or markings are evident in these images, consistentwith the expected cosmetic advantages of reducing skin area by formationof many very small holes.

Table 1 below shows the measured width and height (X and Y,respectively) of each test site on Day 0, Day 7, and Day 28. The datasuggest that the width of sites 1, 2, 4, 5 and 6 decreased slightly overthe course of the observations, and that they tended to widen a bitbetween Day 7 (when the compressive dressing was removed) and Day 28,which may be partially attributed to relaxation of the unconstrainedskin. The width of test site 3 increased between Day 0 and Day 7 becausethis site was compressed in the vertical direction, orthogonal to theother test sites. Similarly, the height of the test sites (except forsite 3), orthogonal to the compressive direction, appears to haveremained about the same or increased slightly between Day 0 and Day 20.

TABLE 1 Measured dimensions of each test site (in cm) at Day 0, 7, and28 Test Day Day Day Day Day Day Site 0 X 0 Y 7 X 7 Y 28 X 28 Y 1 3.4 3.12.8 2.8 3.2 3.4 2 3.2 3.0 3.0 2.8 3.25 3.3 3 3.15 3.0 3.8 2.3 3.1 2.95 43.8 3.0 3.3 2.7 3.4 3.1 5 3.2 3.2 3.2 3.05 3.05 3.2 6 3.4 2.9 2.7 2.63.0 3.4

It should be noted that there was some net growth of the animal subjectover the course of the observations. To correct for this, the width andheight of each control site was measured at Day 0, 7 and 28. Themeasured width and height of each test site was then normalized by theaverage width and height, respectively, of the control sites measured onthe same day. This provides a rough correction for overall growth of theanimal subject (i.e., general increase in skin area) betweenmeasurements of the test site dimensions. Table 2 below includes thewidth and height of each control site as measured on Day 0, 7, and 28.

TABLE 2 Measured dimensions of each control site (in cm) at Day 0, 7,and 28 Control Day Day Day Day Day Day Site 0 X 0 Y 7 X 7 Y 28 X 28 Y b3.0 2.6 3.3 2.5 3.95 3.4 c 3.15 2.7 3.25 2.0 3.9 3.15 d 2.9 2.6 2.95 1.83.5 3.2 e 2.95 2.55 2.9 2.6 3.45 3.4 f 3.0 2.4 3.0 2.4 3.6 3.1 g 3.1 2.53.15 2.15 3.5 3.15 h 2.9 2.6 2.8 2.7 3.65 2.9 Average 3.0 2.56 3.05 2.313.65 3.18

Bar graphs showing the normalized width and height (X and Y,respectively) of each test site are shown in FIGS. 9A and 9B,respectively. The data in these graphs suggest that there was anoticeable decrease in width of test sites 1, 2, 4, 5 and 6 over the 4weeks following the initial treatment, when overall growth of the animalsubject was accounted for. There also appears to also be a slightlyless-marked decrease in the height of these test sites (orthogonal tothe compressive direction) over the same period. Thus, there appears tobe some preferred directionality in the shrinkage of the test subjectskin when treated in accordance with embodiments of the presentdisclosure.

The observed effects (and differences in behavior between the X and Ydirections) are somewhat modest in this exemplary study. A few factorsshould be noted when assessing these measured results. First, there arequalitative differences between human and swine skin. It is expectedthat human skin, being thinner and less resilient, may be more affectedunder similar treatment conditions. Second, the fractional area of skinremoved in each test area was only 6%, which is relatively low. Moremarked results are likely to appear if a larger number of holes wasformed within each test area (corresponding to a larger fraction of skinremoved, e.g., up to 25-30% or more). Also, the dressing did not alwaysadhere very well to the skin of the animal subject, and tends to adheremore strongly to human skin, thus providing more effective compressiveforces. Further, net growth of the animal subject during the observationperiod, although addressed in the data analysis, may still affect thenormalized results. Such “net growth” effects would not typically bepresent in mature human patients, so the actual skin shrinkage may begreater and associated directional differences may be greater.

SUMMARY

It will thus be appreciated that those skilled in the art will be ableto devise numerous systems, arrangements and methods which, although notexplicitly shown or described herein, embody the principles of thedisclosure and are thus within the spirit and scope of the presentdisclosure. In addition, all publications, patents, and patentapplications referenced herein are incorporated herein by reference intheir entireties.

What is claimed is:
 1. A cosmetic method for producing an effect in skintissue, comprising: forming a plurality of holes in a region of the skintissue using at least one coring needle; and providing a stress that isat least one of a compressive stress or a tensile stress in the regionof skin tissue after forming the holes, wherein a diameter of the holesis between about 0.2 mm and 0.7 mm, wherein the holes extend from theskin surface into the dermal layer of the skin, wherein the holes extendover an areal fraction of a surface of the region that is between about5% and 50%, wherein the stress provides a force in the region along adirection that is substantially parallel to the surface of the region,and wherein the stress is maintained on the surface of the region untilthe holes have substantially closed.
 2. The method of claim 1, wherein adiameter of the holes is between about 0.2 mm and 0.5 mm.
 3. The methodof claim 1, wherein the holes extend over the areal fraction of thesurface of the region that is between about 10% and 30%.
 4. The methodof claim 1, wherein the holes extend through an entire depth of thedermal layer.
 5. The method of claim 1, wherein the stress is thecompressive stress which is provided by adhering a pre-stretched filmover at least one portion of the region.
 6. The method of claim 5,further comprising adhering a rigid object onto the pre-stretched filmafter the pre-stretched film has been adhered to the at least oneportion of the region.
 7. The method of claim 6, wherein the rigidobject is at least one of a rigid film or a plate.
 8. The method ofclaim 1, wherein the stress is the compressive stress that is providedby inserting at least one of a surgical staple or a tensioning clip intoor adjacent to the region.
 9. The method of claim 1, wherein the stressis the compressive stress, which is provided by inserting at least onesuture into or adjacent to the region.
 10. The method of claim 1,wherein the stress is the compressive stress, which is provided byadhering a heat-shrink film onto at least a portion of the region andthen heating the heat-shrink film.
 11. The method of claim 1, whereinthe stress is the compressive stress, which is provided by applying acurable liquid onto at least a portion of the region and allowing theliquid to cure, wherein the curable liquid is a liquid that shrinks whencuring.
 12. The method of claim 1, wherein the stress is the tensilestress, which is provided by stretching at least a portion of the regionand then adhering a rigid object onto the stretched region.
 13. Themethod of claim 12, wherein the rigid object is at least one of a rigidfilm or a plate.
 14. The method of any one of claims 5-13, wherein thestress is maintained for at least 4 days.
 15. The method of claim 1,further comprising applying at least one of a biological glue or anadhesive to at least one portion of the region after forming the holes,and maintaining the stress until the glue or the adhesive has at leastpartially set.
 16. The method of claim 1, further comprising applying aphotoactivated substance to at least one portion of the region, anddirecting light energy onto the region while maintaining the stressuntil the adhesive has been activated.
 17. The method of claim 16,wherein the photoactivated adhesive comprises at least one of rosebengal, riboflavin, a porphyrin, a chlorine, or a photosensitizerprecursor.
 18. A system for producing a cosmetic effect in skin tissue,comprising: at least one coring needle structured to form a plurality ofholes in a region of the skin tissue; and a compression arrangementconfigured to produce and maintain a compressive stress over at leastone portion of the region after the holes are formed, wherein an innerdiameter of the at least one coring needle is between about 0.2 mm and0.7 mm, wherein the at least one needle is capable of forming orstructured to form the holes that extend from the skin surface into thedermal layer of the skin, and wherein the compression arrangement isconfigured to maintain the stress that provides a force in the regionalong a direction that is substantially parallel to the skin surfaceuntil the holes have substantially closed.
 19. The system of claim 18,wherein the at least one coring needle comprises a plurality of coringneedles.
 20. The system of claim 18, wherein the inner diameter of theat least one coring needle is between about 0.2 mm and 0.5 mm.
 21. Thesystem of claim 18, wherein the at least one needle is structured toform the holes that extend from the skin surface through the entiredermal layer of the skin.
 22. The system of claim 18, wherein thecompression arrangement is configured to adhere a pre-stretched film toat least a portion of the region of skin.
 23. The system of claim 18,wherein the compression arrangement is configured to adhere a rigidmaterial to at least a portion of the stressed region of skin.
 24. Thesystem of claim 18, wherein the compression arrangement is configured toapply at least one of a surgical staple or a suture onto or adjacent tothe region of skin.